EU Accelerated Assessment Tracker
The outcomes of six requests for accelerated assessment that companies have made for their planned marketing authorization applications in the EU are still unknown.
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Roche Takes Orphan Satralizumab To EMA
There are six new entries on the latest list of products under review at the European Medicines Agency – products with orphan status from Roche and Novo Nordisk and four generic or biosimilars.
Roche’s Polivy Reverts To Standard Review In EU
Just two products are being assessed under the EMA's fast-track mechanism now that the marketing application for Roche's Polivy has reverted to standard review.
Vertex Among Four Hopefuls Seeking EMA's Elusive Speedy Review
Vertex’s triple combination regimen for cystic fibrosis and two Ebola vaccines from Janssen are among the latest potential new products being considered for accelerated assessment by the European Medicines Agency.